PALO ALTO, Calif., Feb. 8 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) today reported financial results
for the fourth quarter and full year ended December 31, 2006. For
the quarter ended December 31, 2006, the Company reported a net
loss of $68.1 million, or $1.18 per share. This compares to a net
loss of $74.1 million, or $1.65 per share, for the same quarter in
2005 and to a net loss of $62.7 million, or $1.23 per share, for
the prior quarter ended September 30, 2006. For the year ended
December 31, 2006, the Company reported a net loss of $274.3
million, or $5.49 per share, compared to a net loss of $228.0
million, or $5.66 per share, for the year ended December 31, 2005.
For the quarter ended December 31, 2006, the Company recorded $9.0
million of net product sales for sales of Ranexa(R) (ranolazine
extended-release tablets), compared to $8.2 million of net product
sales recorded in the quarter ended September 30, 2006. Total net
Ranexa product sales of $8.2 million recorded in the quarter ended
September 30, 2006 included $3.2 million of net product sales made
in that quarter and approximately $5.0 million related to net
product sales made in the quarter ended March 31, 2006 which had
been deferred due to product return privileges that expired in the
quarter ended September 30, 2006. The $9.0 million of net product
sales of Ranexa made in the quarter ended December 31, 2006
represents an 181 percent increase over the $3.2 million of net
product sales made in the prior quarter ended September 30, 2006.
For the full year ended December 31, 2006, the Company recorded
total revenues of $36.8 million which consisted of $18.4 million of
net product sales of Ranexa, $16.9 million of collaborative
research revenue and $1.4 million of co-promotion revenue related
to ACEON(R) (perdindopril erbumine) Tablets. This represents a 94
percent increase over total revenues of $19.0 million for the year
ended December 31, 2005, which consisted solely of collaborative
research revenue. The Company received FDA approval for Ranexa on
January 27, 2006 and commenced commercial product sales of Ranexa
in March 2006. Collaborative research revenue is primarily related
to payments for certain regadenoson development activities from a
collaborative partner and amortization of up-front payments earned.
Co-promotion revenue represents the Company's share of ACEON(R)
product revenues that exceeded the baseline specified in the
amended co-promotion agreement with Solvay Pharmaceuticals, Inc. In
October 2006 we signed a letter agreement with Solvay
Pharmaceuticals terminating our co-promotion agreement. At December
31, 2006, the Company had cash, cash equivalents, marketable
securities and restricted cash of approximately $336.7 million,
compared to $481.8 million at December 31, 2005. Total costs and
expenses were $82.3 million for the quarter ended December 31,
2006. This compares to total costs and expenses of $75.4 million
for the same quarter in 2005 and $76.3 million for the prior
quarter ended September 30, 2006. For the year ended December 31,
2006, total costs and expenses were $315.3 million compared to
$243.0 million for the same period in the prior year. The increase
in total costs and expenses for the quarter as well as the year
ended December 31, 2006 compared to the same periods in the prior
year was primarily due to higher selling, general and
administrative expenses associated with the Company's marketing of
Ranexa, including greater expenses associated with the Company's
national cardiovascular specialty sales force recruited in 2005 and
higher personnel related expenses in various functional areas to
support the Company's increased commercialization activities and
higher personnel related expenses in research and development.
These increases were partially offset by lower marketing expenses
related to the co- promotion of ACEON(R), lower external general
and administrative expenses and lower external expenses for
research and development activities related to regadenoson. The
increase in total costs and expenses for the quarter ended December
31, 2006 compared to the prior quarter ended September 30, 2006 was
primarily due to higher clinical trial expenses related to the
MERLIN TIMI-36 study of Ranexa, higher selling, general and
administrative expenses associated with the Company's national
cardiovascular specialty sales force and higher personnel related
expenses in various functional areas to support the Company's
increased commercialization activities and higher marketing
expenses associated with the marketing of Ranexa. These increases
were partially offset by lower external general and administrative
expenses and lower marketing expenses related to the co-promotion
of ACEON(R). Company management will webcast a conference call on
February 8, 2007 at 5:30 p.m. EST, 2:30 p.m. PST, on the Company's
website. To access the live webcast, please log on to the Company's
website at http://www.cvt.com/ and go to the Investor Information
section. Alternatively, domestic callers may participate in the
conference call by dialing (888) 370-6121, and international
callers may participate in the conference call by dialing (706)
679-7163. Webcast and telephone replays of the conference call will
be available approximately two hours after the completion of the
call through Friday, February 16, 2007. Domestic callers can access
the replay by dialing (800) 642-1687, and international callers can
access the replay by dialing (706) 645-9291; the PIN access number
is 6795246. About CV Therapeutics CV Therapeutics, Inc.,
headquartered in Palo Alto, California, is a biopharmaceutical
company focused on applying molecular cardiology to the discovery,
development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases. CV Therapeutics'
approved product, Ranexa(R) (ranolazine extended-release tablets),
is indicated for the treatment of chronic angina in patients who
have not achieved an adequate response with other antianginal
drugs, and should be used in combination with amlodipine,
beta-blockers or nitrates. CV Therapeutics also has other clinical
and preclinical drug development candidates and programs, including
regadenoson, which is being developed for potential use as a
pharmacologic stress agent in myocardial perfusion imaging studies
and CVT-6883, which is being developed as a potential treatment for
asthma and other conditions. Regadenoson and CVT-6883 have not been
determined by any regulatory authorities to be safe or effective in
humans for any use. Except for the historical information contained
herein, the matters set forth in this press release, including
statements as to research and development and commercialization of
products, are forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ
materially, including operating losses and fluctuations in
operating results; capital requirements; regulatory review and
approval of our products; special protocol assessment agreement;
the conduct and timing of clinical trials; commercialization of
products; market acceptance of products; product labeling;
concentrated customer base; and other risks detailed from time to
time in CV Therapeutics' SEC reports, including its Quarterly
Report on Form 10-Q for the quarter ended September 30, 2006. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. CV THERAPEUTICS, INC. CONSOLIDATED
STATEMENT OF OPERATIONS DATA (in thousands, except per share
amounts) (unaudited) Three months ended Year ended December 31,
December 31, 2006 2005 2006 2005 Revenues: Product sales, net
$9,029 $- $18,423 $- Collaborative research 3,640 3,432 16,923
18,951 Co-promotion - - 1,439 - Total revenues 12,669 3,432 36,785
18,951 Costs and expenses: Cost of sales 1,236 - 2,752 - Research
and development 38,102 33,979 135,254 128,452 Selling, general and
administrative 42,956 41,398 177,264 114,543 Total costs and
expenses 82,294 75,377 315,270 242,995 Loss from operations
(69,625) (71,945) (278,485) (224,044) Other income (expense), net:
Interest and other income, net 4,731 1,059 16,832 9,092 Interest
expense (3,166) (3,166) (12,667) (13,043) Total other income
(expense), net 1,565 (2,107) 4,165 (3,951) Net loss $(68,060)
$(74,052) $(274,320) $(227,995) Basic and diluted net loss per
share $(1.18) $(1.65) $(5.49) $(5.66) Shares used in computing
basic and diluted net loss per share 57,823 44,884 49,983 40,268
CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) December
31, December 31, 2006 2005 (A) Assets: Cash, cash equivalents, and
marketable securities $325,226 $460,183 Other current assets 40,269
26,883 Total current assets 365,495 487,066 Property and equipment,
net 23,919 20,491 Other assets 32,042 25,004 Total assets $421,456
$532,561 Liabilities and stockholders' equity (deficit): Current
liabilities $62,247 $63,527 Convertible subordinated notes 399,500
399,500 Other long-term obligations 5,507 8,544 Stockholders'
equity (deficit) (45,798) 60,990 Total liabilities and
stockholders' equity (deficit) $421,456 $532,561 (A) Derived from
the audited financial statements included in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2005. Certain
reclassifications have been made to prior period balances to
conform to the current presentation. DATASOURCE: CV Therapeutics,
Inc. CONTACT: Investor & Media: John Bluth, Senior Director,
Corporate Communications & Investor Relations of CV
Therapeutics, Inc., +1-650-384-8850 Web site: http://www.cvt.com/
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